Paranasal sinus access implant devices and related tools, methods and kits

ABSTRACT

A paranasal sinus access implant device to provide an artificial fluid path in fluid communication with the lacrimal apparatus may be implanted through a fistula opening into the lacrimal apparatus. The implant device may have a conduit with a first longitudinal portion having a larger minimum wall thickness than a minimum wall thickness of a second a second longitudinal portion of the conduit located distal of the first longitudinal portion. Various kits may include a paranasal sinus access implant device and one of more other components for a procedure involving implantation. A method involves use of a cutting tool to cut away tissue to prepare a fistula sized for implantation.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/424,841 entitled “PARANASAL SINUS ACCESS IMPLANT DEVICES AND RELATEDTOOLS, METHODS AND KITS” having a 371(c) date of Feb. 27, 2015, which isa U.S. national stage filing under the Patent Cooperation Treaty ofinternational patent application no. PCT/US2014/012995 filed Jan. 24,2014, which claims the benefit of U.S. provisional patent applicationNo. 61/757,046 entitled “IMPLANT DEVICE, METHOD AND KIT FOR IMPLANTATIONBETWEEN THE LACRIMAL SYSTEM AND A PARANASAL SINUS” filed Jan. 25, 2013and the benefit of U.S. provisional patent application No. 61/891,250entitled “PARANASAL SINUS ACCESS IMPLANT DEVICES AND RELATED TOOLS,METHODS AND KITS” filed Oct. 15, 2013, and the entire contents, and eachand every portion thereof, of each of the foregoing identifiedapplications is incorporated by reference herein.

This application incorporates by reference each and every portion of thefollowing: international patent application no. PCT/US2011/055456entitled “IMPLANT DEVICE, TOOL, AND METHODS RELATING TO TREATMENT OFPARANASAL SINUSES” filed Oct. 7, 2011 (which entered the PCT nationalstage in the U.S. as U.S. patent application Ser. No. 13/877,893 and isnow issued as U.S. Pat. No. 9,308,358); U.S. nonprovisional patentapplication Ser. No. 13/225,213 (now issued as U.S. Pat. No. 9,022,967)entitled “IMPLANT DEVICE, TOOL, AND METHODS RELATING TO TREATMENT OFPARANASAL SINUSES” filed Sep. 2, 2011; U.S. provisional patentapplication No. 61/528,058 entitled “IMPLANT DEVICE, TOOL, AND METHODSRELATING TO TREATMENT OF PARANASAL SINUSES” filed Aug. 26, 2011; U.S.provisional patent application No. 61/404,716 entitled “METHODS ANDTOOLS FOR TREATMENT AND PREVENTION OF SINUSITIS” filed Oct. 8, 2010;U.S. provisional patent application No. 61/623,022 entitled“IMPLANTATION TOOLS, TOOL ASSEMBLIES, KITS AND METHODS” filed Apr. 11,2012; and international patent application no. PCT/US2013/03447 entitled“IMPLANTATION TOOLS, TOOL ASSEMBLIES, KITS AND METHODS” filed Mar. 28,2013.

FIELD OF THE INVENTION

The invention relates to treatment of conditions of the paranasalsinuses, including with respect to paranasal sinus access implantdevices, surgical tools, methods and kits.

BACKGROUND OF THE INVENTION

In the United States alone, 35 million people a year are treated forsinus infections, or sinusitis, and 7 million of those will suffer fromchronic sinusitis and will have minimal response to prescription drugtherapies. Conventional surgical interventions may be expected to, atbest, offer only moderate symptomatic improvement but no cure.

Conventional drug therapies include oral administration as pills andnasal topical administration, neither of which is conducive todelivering adequate concentration of medication to the involvedparanasal sinus. In addition to medication, frequent sinus irrigationcan be helpful in flushing out debris, irritants and obstructing viscousfluids, but patients are generally not able to adequately perform thisprocedure at home.

For patients with particularly severe symptoms, surgical drainage hasbeen an option of last resort. An early surgical procedure was theCaldwell-Luc procedure, which involves creating a permanent fistula fromthe base of the paranasal sinus into the oral cavity above the frontupper incisors. More recently, other surgical access points to theparanasal sinuses have been attempted. A variety of endoscopictechniques have been developed that access the paranasal sinuses throughthe nose, including functional endoscopic sinus surgery (FESS) andballoon sinuplasty. All attempt to increase drainage, but utilizedifferent routes or tools. Surgical formation of a fistula between thelacrimal apparatus and a paranasal sinus has been identified as atechnique to provide direct access to the paranasal sinus, and throughwhich a variety of medical treatments and medical procedures may bedirected to the paranasal sinus. None of these surgical approaches hasyet achieved wide-spread acceptance or success, and millions of chronicsinusitis patients continue to suffer long-term disability anddiscomfort.

SUMMARY OF INVENTION

Paranasal sinus access implant devices may be configured to be implantedin a human to provide fluid access to a paranasal sinus through aninternal passage of such a paranasal sinus access implant device. Suchparanasal sinus access implant devices have significant potential forperformance of medical procedures and treatments of paranasal sinuses,but such potential has not yet been realized, and there is a continuedneed for implant devices and accompanying procedures that facilitateeasy and effective implantation with good anchoring of the implantdevice, patient comfort, implant device durability post implantation andeffective performance of medical procedures. Various aspects of thisdisclosure relate to paranasal sinus access implant devices, tools andmethods for implantation procedures and treatments through implantedimplant devices and kits including paranasal sinus access implantdevices. For brevity, paranasal sinus access implant devices aresometimes referred to herein as simply implant devices.

A first aspect of the disclosure involves an implant device useful forimplantation in a human to fluidly connect a lacrimal apparatus to aparanasal sinus through a fistula formed between the lacrimal apparatusand the paranasal sinus.

It has been found that implant devices may be better retained followingimplantation if the implant devices include anchoring surface featuresincluding protrusion areas and recess areas along a conduit that is tobe inserted into the fistula for implantation. Anchoring is enhancedwhen a maximum outside diameter defined by protrusion areas to bedisposed in the fistula is larger than the diameter of the fistula thatwas formed to accept the conduit of the implant device. This creates asnug fit of the conduit in the fistula, with tissue forcing itself intothe recess areas of the anchoring surface feature. However, suchimplantation conduits made of relatively flexible plastic materials maybunch up, such as in the manner of an accordion, making it difficult toinsert the conduit into the fistula for implantation. It has been foundthat by including a thicker conduit wall in a proximal portion of theconduit of an implant device than is included in a distal portion thatis inserted first into the fistula, that the ease of insertion of theconduit may be significantly improved. In addition, a thicker conduitwall in a proximal portion of the conduit provides added mechanicaldurability of the conduit adjacent the proximal end of the implantdevice and reducing potential for mechanical damage to proximal portionsof the conduit due to mechanical interactions that may occur between theimplant device and tools used during an implantation procedure or duringperformance of medical treatments and other procedures followingimplantation.

The implant device of the first aspect may include:

a proximal end at a first longitudinal end of the device;

a distal end at a second longitudinal end of the device that islongitudinally opposite the first longitudinal end;

a conduit located between the proximal end and the distal end;

an internal passage through the conduit;

a length of the implant device longitudinally along the implant devicebetween the proximal end and the distal end in a range of from 2millimeters to 50 millimeters;

a width of the internal passage transverse to the length in a range offrom 0.25 millimeter to 5 millimeters;

the conduit including a first longitudinal portion and a secondlongitudinal portion located toward the distal end relative to the firstlongitudinal portion;

the first longitudinal portion of the conduit having a minimum wallthickness (first minimum wall thickness) adjacent the internal passage;and

the second longitudinal portion of the conduit having a minimum wallthickness (second minimum wall thickness) adjacent the internal passagethat is smaller than the first minimum wall thickness;

the implant device configured to be implanted to fluidly connect thelacrimal apparatus to the paranasal sinus so that when implanted:

-   -   the proximal end is disposed in the lacrimal apparatus;    -   the distal end is disposed in the paranasal sinus; and    -   the conduit is disposed through the fistula with at least a        portion of each of the first longitudinal portion and the second        longitudinal portion of the conduit disposed within the fistula        and with at least a portion of the second longitudinal portion        of the conduit disposed in the paranasal sinus.

A number of feature refinements and additional features are applicableto the first aspect of the disclosure. These feature refinements andadditional features may be used individually or in any combinationwithin the subject matter of the first aspect or any other aspect of thedisclosure. As such, each of the following features may be, but are notrequired to be, used with any other feature or combination of featuresof the first aspect or any other aspect of the disclosure.

The first longitudinal portion of the conduit may or may not have auniform wall thickness. The first longitudinal portion of the conduitmay have a smooth exterior surface. The first longitudinal portion ofthe conduit may have a length of at least 3 millimeters, at least 4millimeters, at least 5 millimeters, at least 8 millimeters or at least10 millimeters. The first longitudinal portion of the conduit may oftenhave a length that is no greater than 20 millimeters, no greater than 15millimeters, no greater than 12 millimeters or no greater than 10millimeters.

The first minimum wall thickness may be at least 0.25 millimeter, atleast 0.3 millimeter, at least 0.35 millimeter or at least 0.4millimeter. The first minimum wall thickness may often be no greaterthan 0.75 millimeter, no greater than 0.6 millimeter, no greater than0.55 millimeter, no greater than 0.5 millimeter or no greater than 0.45millimeter. The wall thickness of the first longitudinal portion of theconduit may be substantially the same and equal to the first minimumwall thickness over some portion of or the entire length of the firstlongitudinal portion.

The second longitudinal portion of the conduit may have a length of atleast 3 millimeters, at least 4 millimeters, at least 5 millimeters, atleast 8 millimeters or at least 10 millimeters. The second longitudinalportion of the conduit may often have a length that is no greater than30 millimeters, no greater than 25 millimeters, no greater than 20millimeters, no greater than 15 millimeters, no greater than 12millimeters or no greater than 10 millimeters.

The second minimum wall thickness may be no greater than 0.6 millimeter,no greater than 0.5 millimeter, no greater than 0.45 millimeter, nogreater than 0.4 millimeter, no greater than 0.35 millimeter, no greaterthan 0.3 millimeter, no greater than 0.25 millimeter or no greater than0.2 millimeter. The second minimum wall thickness may often be at least0.1 millimeter, at least 0.15 millimeter or at least 0.2 millimeter. Thewall thickness of the second longitudinal portion of the conduit may besubstantially the same over some portion or portions of the secondlongitudinal portion of the conduit. The second longitudinal portion ofthe conduit may have an exterior including an anchoring surface featureincluding protrusion areas and recess areas. The wall thickness atlocations corresponding with the recess areas may be smaller than thewall thickness at locations corresponding with the protrusion areas. Thesecond minimum wall thickness may occur at one or more locationscorresponding with one or more of such recess areas.

The first minimum wall thickness may be at least 0.05 millimeter larger,at least 0.1 millimeter larger, at least 0.15 millimeter or at least0.175 millimeter larger than the second minimum wall thickness. Thefirst minimum wall thickness may be no more than 0.3 millimeter larger,no more than 0.25 millimeter larger or no more than 0.2 millimeterlarger than the second minimum wall thickness.

The first longitudinal portion of the conduit may have a maximumexterior width (first maximum exterior width) that is smaller than amaximum exterior width of the second longitudinal portion of the conduit(second maximum exterior width). The second maximum exterior width maybe at least 0.1 millimeter larger, at least 0.2 millimeter larger, atleast 0.25 millimeter larger, at least 0.3 millimeter larger, at least0.35 millimeter larger, at least 0.4 millimeter larger or at least 0.5millimeter larger than the first maximum exterior width. The secondmaximum exterior width may often be no more than 1 millimeter, no morethan 0.75 millimeter, no more than 0.5 millimeter or no more than 0.4millimeter larger than the first maximum exterior width. The firstmaximum exterior width may be at least 1.25 millimeters, at least 1.5millimeters, at least 1.75 millimeters or at least 2 millimeters. Thefirst maximum exterior width may often be no greater than 3 millimeters,no greater than 2.5 millimeters, no greater than 2.25 millimeters or nogreater than 2 millimeters. The second maximum exterior width may be atleast 1.5 millimeters, at least 1.6 millimeters at least 1.75millimeters, at least 2 millimeters, at least 2.25 millimeters or atleast 2.5 millimeters. The second maximum exterior width may be nogreater than 5 millimeters, no greater than 4 millimeters, no greaterthan 3 millimeters, no greater than 2.75 millimeters, no greater than2.5 millimeters or no greater than 2.25 millimeters.

The first longitudinal portion of the conduit may have a minimumexterior width (first minimum exterior width) and the secondlongitudinal portion of the conduit may have a minimum exterior width(second minimum exterior width) that is smaller than the first maximumexterior width. The first minimum exterior width may be at least 0.1millimeter larger, at least 0.2 millimeter larger, at least 0.25millimeter larger, at least 0.3 millimeter larger, at least 0.35millimeter larger, at least 0.4 millimeter larger or at least 0.5millimeter larger than the second minimum exterior width. The firstminimum exterior width may be no greater than 3 millimeters, no greaterthan 2.5 millimeters, no greater than 2.25 millimeters or no greaterthan 2 millimeters. The first minimum exterior width may be at least 1millimeter, at least 1.25 millimeters, at least 1.5 millimeters, atleast 1.75 millimeters or at least 2 millimeters. The first longitudinalportion of the conduit may have a substantially constant cross-section(e.g., constant circular cross-section), in which case the maximum andminimum exterior widths of the first longitudinal portion of the conduitare the same (e.g., diameter of constant circular cross-section). Thesecond minimum exterior width may be no greater than 2.5 millimeters, nogreater than 2 millimeters, no greater than 1.75 millimeters or nogreater than 1.5 millimeters. The second minimum exterior width mayoften be at least 1 millimeter, at least 1.25 millimeter, at least 1.50millimeters or at least 1.75 millimeters. The second longitudinalportion may have a surface geometry wherein the second minimum exteriorwidth may be smaller than a second maximum exterior width of the secondlongitudinal portion. The second minimum exterior width may correspondwith locations of the second minimum wall thickness.

The conduit may have a circular cross-section at some or all pointsalong the length of the first and second longitudinal portions of theconduit. The first minimum wall thickness and the second minimum wallthickness may be tubular walls.

The conduit may be configured so that an exterior of the conduitcomprises an anchoring surface feature that assists to anchor theimplant device when the device is implanted. The anchoring surfacefeature includes protrusion areas and recess areas. The second minimumwall thickness may occur at a location corresponding with at least oneof the recess areas. The implant device may be configured so that whenimplanted the conduit is disposed through the fistula with at least aportion of the recess areas disposed within the fistula and with atleast a portion of the protrusion areas disposed in the fistula andengaging tissue exposed within the fistula to anchor the implant device.The structural and mechanical characteristics of protrusion occurrencesin the protrusion areas may affect anchoring performance of theprotrusion areas. The height of the protrusion areas relative to therecess areas may affect anchoring effectiveness when the implant deviceis implanted. A larger height may provide greater anchor effectiveness,but also may involve a larger overall width of the implant device thatmust be inserted into the fistula. The protrusion areas may have aheight relative to the recess areas of at least 0.1 millimeter, at least0.2 millimeter, at least 0.25 millimeter or at least 0.3 millimeter. Theprotrusions areas may have a height relative to the recess areas of nogreater than 2 millimeters, no greater than 1.5 millimeter, no greaterthan 1 millimeter, no greater than 0.75 millimeter, no greater than 0.5millimeter or no greater than 0.4 millimeter. The height may be ofparticular protrusion occurrences relative to adjacent areas ofrecesses. Protrusion occurrences are also referred to herein as anchorprotrusions. Such anchor protrusions may be configured to flexiblydeform when the conduit is inserted through the fistula forimplantation, for example to flexibly deform in a direction opposite thedirection of insertion when the anchor protrusions contact tissuedisposed in the fistula during insertion. After insertion, the anchorprotrusions may over time return to their original shape and extenddeeper into adjacent tissue to better anchor the implant device. Themechanical properties of the anchor protrusions may be influenced bymaterials of construction. Preferred materials of construction for theprotrusion areas, and also for the other portions of the implant device,are polymeric materials. The polymeric materials may preferably bemedical grade materials. Some preferred polymeric materials aresilicones and polyurethanes. For enhanced performance, the material ofconstruction should have a rigidity that interacts positively withtissue in the vicinity of the fistula, for example to promote loadsharing and good anchoring. One preferred material of construction is apolymeric material (e.g. silicone or polyurethane) having a durometer(Shore A) in a range having a lower limit of 50, 60, 70 or 80 and anupper limit of 100, 80, 70 or 60, provided that the upper limit must belarger than the lower limit. One preferred range is for a durometer(Shore A) of 60-100, with a range of 80-100 being even more preferred.For some implementations the polymeric material has a durometer (ShoreA) of about 60, of about 80 or of about 100. Mechanical properties ofthe protrusion occurrences of the protrusion areas will also be affectedby the geometry of the protrusion occurrences. The protrusionoccurrences may have a width that tapers, or narrows, in a directionfrom a base toward a top of the protrusion occurrences, with the basebeing a portion of a protrusion occurrence disposed toward the internalpassage of the conduit and a top of the protrusion occurrence being theextremity of the protrusion occurrence away from the internal passage ofthe conduit. The width may be transverse to the length of the conduit.The protrusion occurrences may have a width at the base that is nolarger than 2 millimeters, no larger than 1.5 millimeters, no largerthan 1.25 millimeters or no larger than 1 millimeter. One or more of theprotrusion occurrences may have a width at the base that is at least 0.2millimeter, at least 0.3 millimeter, at least 0.5 millimeter, at least0.75 millimeter or at least 1 millimeter. The protrusion occurrences mayhave a width adjacent the top that is no larger than 0.75 times width atthe base, no larger than 0.5 times the width at the base, or no largerthan 0.25 times the width at the base. The protrusion occurrences mayhave a width midway between the base and the top that is no larger than0.8 times the width of the base, no larger than 0.7 times the width ofthe base, no larger than 0.6 times the width of the base or no largerthan 0.5 times the width at the base.

The protrusion areas may be provided by a single protrusion occurrencefeature located to correspond with the interior of the fistula when theimplant device is implanted. In more preferred implementations, theprotrusion areas include multiple protrusion occurrences spaced on theexterior of the conduit. The protrusion occurrences may have acenter-to-center spacing, in one or more directions, of at least 0.5millimeter, at least 0.75 millimeter, at least 1 millimeter or at least1.75 millimeters. The protrusion occurrences may have a center-to-centerspacing of no greater than 2.5 millimeters, no greater than 2millimeters or no greater than 1.75 millimeters. The protrusionoccurrences may have a center-to-center spacing longitudinally along theconduit. The protrusion occurrences may have a center-to-center spacingthat is at least 0.5 times the base width of the protrusion occurrences,or at least 1 times the base width of the protrusion occurrences or atleast 2 times the base width of the protrusion occurrences. Theprotrusion occurrences may have a center-to-center spacing that is nomore than 5 times a base width of the protrusion occurrences, no morethan 3 times a base width of the protrusion occurrences or no more than2 times a base width of the protrusion occurrences.

The protrusion areas may be located on a longitudinal portion of theconduit that includes at least a portion of the conduit that will bedisposed within a fistula when the implant device is implanted. Theprotrusion areas may be on a longitudinal portion of the conduit thatextends for at least 2 millimeters along the length of the implantdevice, that extends for at least 3 millimeters along the length of theimplant device, that extends for at least 4 millimeters along the lengthof the implant device, that extends for at least 5 millimeters along thelength of the implant device or that extends for at least 8 millimetersalong the length of the implant device. A longitudinal portion of theconduit including the protrusion areas may be no longer than 20millimeters, no longer than 15 millimeters or no longer than 10millimeters. A longitudinal portion of the conduit including theprotrusion areas may be disposed at least 2 millimeters from theproximal end of the device, at least 3 millimeters from the proximal endof the device, or at least 4 millimeters from the proximal end of thedevice. When the implant device has a head, a longitudinal portion ofthe conduit including the protrusions may be disposed at least 1millimeter, at least 2 millimeters or at least 3 millimeters from thehead. Providing significant distance between the head and commencementof the protrusion areas permits the head to better “float” on thesurface of tissue, which may enhance patient comfort and deviceperformance. The protrusion areas may be disposed along a longitudinalportion of the conduit with the protrusion areas covering no more than35% of the area along that longitudinal portion of the conduit, no morethan 25% of the area along that longitudinal portion of the conduit ornot more than 20% of the area along that longitudinal portion of theconduit. Providing significant spacing between protrusion occurrencesmay permit better engagement of tissue by the anchoring surface feature.Some or all of the protrusion occurrences may be on the secondlongitudinal portion of the conduit.

The protrusion areas may comprise at least one circumferential ridge. Bycircumferential ridge is meant a ridge that extends around an entirecircumference of the conduit. The protrusion area may comprise at leasttwo, at least three or at least five circumferential ridges. Theprotrusion areas may comprise a spiral ridge. Such a spiral ridge mayextend along a longitudinal portion of the conduit. The protrusion areasmay comprise a knob or may comprise multiple knobs. The anchoringsurface feature may comprise a textured surface, with the protrusionareas comprising protruding portions of the textured surface and therecess areas comprising recess portions of the textured surface.

The length of the implant device may be selected to provide sufficientconduit length for extending through the entire length of the fistulaplus any extension distance desired in the lacrimal apparatus proximalto the fistula and in the paranasal sinus distal to the fistula. Thelength of the implant device and/or of the conduit may be in a rangehaving a lower limit of 2 millimeters, 3 millimeters, 4 millimeters, 5millimeters, 8 millimeters, 10 millimeters or 12 millimeters and anupper limit of 50 millimeters, 40 millimeters, 30 millimeters, 25millimeters, 20 millimeters, 15 millimeters or 10 millimeters, providedthat the upper limit is larger than the lower limit. One preferred rangefor some implementations when the fistula is between the orbit and theethmoid sinus or the maxillary sinus is for the length of the implantdevice and/or for the length of the conduit to be in a range of from 10millimeters to 30 millimeters, with a range of from 15 millimeters to 25millimeters being more preferred. By length of the implant device orconduit it is meant the dimension longitudinally along the implantdevice or the conduit, as the case may be, from the proximal end to thedistal end of the implant device or conduit, and may be along alongitudinal axis through the internal passage. The length may be astraight line, for example when the internal passage is straight, or thelength may be curvilinear or some other shape, for example when theinternal passage is not linear. When a reference is made herein totransverse to the length, the reference is to a right angle to thelongitudinal direction of the length at that point (e.g., right angle toa line of the length or to a line tangent to a curve of the length).

The implant device may advantageously be designed with a conduit ofappropriate width dimensions to fit snuggly within a desired size offistula. The implant device may have a first exterior width dimensiondefined by a maximum extent of the protrusion areas transverse to thelength of the device, with the first exterior width being within a rangehaving a lower limit of 0.75 millimeter, 1 millimeter, 1.25 millimeters,1.5 millimeters, 1.75 millimeters or 2 millimeters and an upper limit of8 millimeters, 7 millimeters, 6 millimeters, 5 millimeters, 4millimeters, 3 millimeters, 2 millimeters or 1.75 millimeters, providedof course that the upper limit must be larger than the lower limit. Theconduit may have a second width dimension defined by the minimum extentof the recess areas transverse to the length of the device, and whichsecond exterior width dimension will be smaller than the first exteriorwidth dimension defined by the protrusion areas. The second exteriorwidth dimension defined by the recess areas may be smaller than theexterior width dimension defined by the protrusion areas by an amountwithin a range having a lower limit of 0.2 millimeter, 0.25 millimeter,0.35 millimeter or 0.5 millimeter and having an upper limit of 1.5millimeters, 1 millimeter or 0.75 millimeter. The height of theprotrusion areas may be one-half the difference between the firstexterior width and the second exterior width. Either one of or each oneof the first exterior width and the second exterior width may be thediameter of a circle.

The implant device may include one or a plurality of side openingsthrough the conduit wall of a distal portion of the conduit, whichdistal portion may be or include a portion of the conduit that isdesigned to be disposed within a paranasal sinus when the implant deviceis implanted to provide fluid access through the implant device to theparanasal sinus. The side openings may be open into the internal passagethrough the conduit and may provide a passage for fluid communicationbetween the internal passage of the implant device and the paranasalsinus even if the distal opening of the internal passage at the distalend of the conduit were to become blocked or restricted for some reason.One or more of the side openings may be through a wall of the secondlongitudinal portion of the conduit, and may be though a wall having thesecond minimum wall thickness. One or more of the side openings may belocated within one or more recess areas of an anchoring surface featureof the conduit (e.g., between circumferential ridges). With a thinnerminimum wall thickness in the second longitudinal portion of the conduitthan the first longitudinal portion of the conduit, the secondlongitudinal portion of the conduit, and in particular near a distal endof the second longitudinal portion of the conduit, may be more prone torestriction due to collapse of the conduit at or near the distal end,and the side openings 850 provide an alternative fluid access to theparanasal sinus.

The implant device may include a head adjacent to the conduit at theproximal end of the implant device. The implant device may be configuredso that when the implant device is implanted, the head is disposed inthe lacrimal apparatus, and preferably with the head located in theorbit. The head may beneficially keep the implant device from migratingthrough the fistula toward the paranasal sinus following implantation ofthe implant device. The head may comprise a flanged tissue engagementsurface on a side of the head disposed toward the conduit and configuredto engage tissue outside of and adjacent to the fistula when the implantdevice is implanted. The flanged tissue engagement surface may be a flatsurface. The flanged tissue engagement surface may have non-flat surfacefeatures configured to improve seating of the surface against tissue,such as for example to inhibit rotation of the implant device within thefistula after implantation. The head may have a face surface oppositethe flanged tissue engagement surface and also disposed away from theconduit and disposed away from tissue engaged by the flanged tissueengagement surface when the implant device is implanted. The facesurface may be substantially flat. The face surface may be disposed atthe proximal end of the implant device and the internal passage may openat the face surface. The separation distance between the face surfaceand the flanged tissue engagement surface may be in a range having alower limit of 0.25 millimeter, 0.5 millimeter or 0.75 millimeter andhaving an upper limit of 2 millimeters, 1.5 millimeters or 1 millimeter.Such separation distance need not be constant across the flanged tissueengagement surface and face surface. A maximum separation distancebetween the face surface and the flanged tissue engagement surface maybe referred to as the depth of the head, and such depth may be in arange described above for the separation distance between the facesurface and the flanged tissue engagement surface. The flanged tissueengagement surface need not be continuous and may be divided intomultiple distinct surface portions. For example, the flanged tissueengagement surface may include a first flanged portion disposed to oneside of the internal passage and a second flanged surface portiondisposed to a second side of the internal passage that is opposite thefirst side. Each of the face surface and the flanged tissue engagementsurface may have a length dimension that represents a maximum separationdistance between points on an outer edge of the respective surface, andmay each have a width dimension that is a maximum separation distancebetween points on the outer edge transverse to the length dimension. Thelength dimensions of the face surface and the flanged tissue engagementsurface may be the same or may be different. The width dimensions of theface surface and the flanged tissue engagement surface may be the sameor may be different. The face surface and the flanged tissue engagementsurface may have corresponding outer edges. The length dimension of anyor all of the face surface, the flanged tissue engagement surface andthe head may be larger than a first exterior width of the conduitdefined by an extent of the protrusion areas transverse to the length ofthe implant device, when the implant device includes an anchoringsurface feature such as summarized above. The length dimension of any orall of the face surface, the tissue engagement surface and the head maybe in a range having a lower limit of 1 millimeter, 2 millimeters, 3millimeters, 4 millimeters or 5 millimeters and an upper limit of, 10millimeters, 8 millimeters or 7 millimeters. The width dimension of anyor all of the face surface, tissue engagement surface and the head maybe in a range having a lower limit of 0.5 millimeter, 1 millimeter, 1.5millimeters or 2 millimeters and an upper limit of 5 millimeters, 4millimeters or 3 millimeters. The length dimension of any or all of theface surface, the flanged tissue engagement surface and the head may beat least 1 millimeter, at least 2 millimeters, at least 3 millimeters orat least 4 millimeters larger than such first exterior width of theconduit defined by an extent of the protrusion areas, when the implantdevice includes an anchoring surface feature such as summarized above. Aratio of the length of any of or all the face surface, the flangedtissue engagement surface and the head to such a first exterior width ofthe conduit may be at least 2. Such a ratio may be smaller than 4. Thewidth of any or all of the face surface, the flanged tissue engagementsurface and the head may be not larger than, or may be smaller than(e.g., by at least 0.1 mm or by at least 0.2 mm), such a first exteriorwidth of the conduit defined by an extent of the protrusion areas, whenthe implant device includes an anchoring surface feature such assummarized above. A ratio of the length dimension to the width dimensionfor any or all of the face surface, the flanged tissue engagementsurface and the head may be in a range having a lower limit of 1, 1.5, 2or 2.5 and an upper limit of 5, 4, 3 or 2.5, provided of course that theupper limit must be larger than the lower limit. Having a larger lengthdimension to width dimension on the head is particularly preferred whenthe head will be located in the orbit between the lacrimal caruncle andthe plica semilunaris, because the length dimension may advantageouslyalign in a vertical direction next to the eyeball and will help providesufficient flanged surface area to effectively anchor the implant deviceon the proximal end and impede conjunctival tissue from covering theopening into the internal passage of the implant device, compensatingfor the narrower width. This is particularly advantageous when usingpolymeric materials of construction as described above.

The internal passage through the implant device may have a substantiallyuniform shape along the entire length of the implant device, or may havea varying shape. The internal passage may be substantially straight fromthe proximal end of the device to the distal end of the device. Theinternal passage may have a cross-section available for flow (transverseto the length of the device) that is substantially uniform from theproximal end to the distal end of the implant device. The internalpassage may have a substantially circular cross-section. The internalpassage may have a substantially elliptical cross-section. The width ofthe conduit (maximum dimension across the cross-section of the internalpassage available for flow) may be in a range having a lower limit of0.25 millimeter, 0.5 millimeter or 0.75 millimeter and 1 millimeter andan upper limit of 5 millimeters, or 4 millimeters or 3 millimeters, 2millimeters or 1.5 millimeters.

The lacrimal apparatus and a paranasal sinus may be in fluidcommunication through the internal passage of the implant device whenthe implant device is implanted. The conduit may extend from adjacentthe proximal end of the implant device. The conduit may extend toadjacent the distal end of the implant device. The internal passage mayhave a first end open at the proximal end and a second end open at thedistal end, and when the implant device is implanted the first end ofthe internal passage may open in the lacrimal apparatus and the secondend of the internal passage opens in the paranasal sinus

The implant device may be configured for implantation with the conduitpassing through a fistula between a location in a lacrimal apparatuswithin the orbit and a paranasal sinus selected from the groupconsisting of a frontal sinus, an ethmoid sinus, a maxillary sinus and asphenoid sinus, with a frontal sinus, a maxillary sinus or an ethmoidsinus being preferred, with an ethmoid sinus or a maxillary sinus beingmore preferred, and with an ethmoid sinus being particularly preferred.The implant device may be configured for implantation with the conduitpassing through a fistula between a location in the lacrimal apparatuswithin the nasolacrimal duct and a paranasal sinus selected from thegroup consisting of an ethmoid sinus and a maxillary sinus. The locationwithin the nasolacrimal duct may be within the lacrimal sac.

The implant device is primarily configured for and described herein withprimary reference to the implant device being implantable in a fistulathat may be formed between the lacrimal apparatus and a paranasal sinusto provide a passage from the lacrimal apparatus to the paranasal sinus.The implant device is also implantable in a fistula that may be formedbetween the lacrimal apparatus (e.g., from the corner of medial portionof the orbit between the lacrimal caruncle and the plica semilunaris)and the nasal cavity, for example for enhanced drainage of lacrimalfluid, and such applications directed to the nasal cavity are within thescope of the different aspects of the disclosure.

A second aspect of the disclosure involves an implantation kit withcomponents for implantation of an implant device to provide anartificial fluid path in fluid communication with the lacrimalapparatus. A kit of the second aspect may include a paranasal sinusaccess implant device and at least one additional component useful inconnection with implantation of the implant device or performance of amedical treatment or procedure through the implant device.

A number of feature refinements and additional features are applicableto the second aspect of the disclosure. These feature refinements andadditional features may be used individually or in any combinationwithin the subject matter of the second aspect or any other aspect ofthe disclosure. As such, each of the following features may be, but arenot required to be, used within any other feature or combination offeatures of the first aspect, the second aspect or any other aspect ofthe disclosure.

The implant device may comprise:

-   -   a proximal end and a distal end at opposite longitudinal ends of        the implant device;    -   a conduit located between the proximal end and the distal end;    -   an internal passage extending through the conduit;    -   a longitudinal length between the proximal end and the distal        end of the implant device in a range of from 2 millimeters to 50        millimeters;    -   a width of the internal passage transverse to the length in a        range of from 0.25 millimeter to 5 millimeters; and    -   the implant device being configured to be implanted with the        proximal end of the implant device disposed in the lacrimal        apparatus and at least a portion of the conduit disposed in a        fistula opening into the lacrimal apparatus.

The implant device may be an implant device of the first aspect of thedisclosure or may have any feature or combination of features describedfor the first aspect of the disclosure, for example even if the implantdevice is not according to the first aspect.

A kit may include any, or any combination of any, apparatuses, tools,devices, products, components or treatment compositions describedherein.

A kit may include a fluid treatment composition deliverable to aparanasal sinus through the implant device following implantation of theimplant device to provide fluid access to the paranasal sinus. Such afluid treatment composition may be suitable for being conducted to theinternal passage of an implant device through manipulation of a fluiddispenser for delivery to a paranasal sinus, for example to treat forsinusitis or some other condition of the paranasal sinus. The treatmentcomposition may be an aqueous irrigation liquid. The treatmentcomposition may be a drug treatment composition. The drug treatmentcomposition may comprise at least one drug for treating sinusitis orother condition of a paranasal sinus. The drug treatment composition maycomprise one or more of the following: an antibiotic, a steroid, ananti-viral, an antihistamine, an anti-fungal, a mast cell stabilizer, amucolytic, a non-steroidal anti-inflammatory drug (NSAID), avasoconstrictor and an immunosuppressant. Some example antibioticsinclude: sulfa, or sulfonamide, drugs, such as for example sulfacetamide(e.g., in OCUSOL) and sulfisoxazole (e.g., in GANTRISIN®); macrolidedrugs, such as for example azithromycin (e.g., in AZACITE®) anderythromycin (e.g., in ERYPED®); aminoglycoside drugs, such as forexample tobramycin (e.g., in TOBREX®) and gentamicin (e.g., inGENOPTIC®); fluoroquinolone drugs, such as for example ciprofloxacin(e.g., in CILOXAN®), besifloxacin (e.g., in BESIVANCE®) and moxifloxacin(e.g., in VIGAMOX®); tetracycline drugs, such as for exampleoxytetracycline (e.g., in CODEX); and antibiotic drug combinations, suchas for example containing a combination of bacitracin, neomycin andpolymyxin B (e.g., in OCUSPORE B) and a combination of gramicidin,neomycin and polymyxin B (e.g., in NEOCIN PG). Some example antiviralsinclude gancyclovir (e.g., in ZIRGAN®) and trifluridine (e.g., inVIROPTIC®). Some example steroids include loteprednol (e.g., inLOTEMAX®) and prednisolone (e.g., in PRED FORTE®). Some exampleanthistimines include ketotifen (e.g., in ALAWAY®), otopatadine (e.g.,in PATADAY®) and pinastine (e.g., in ELESTAT®). Some example mast cellstabilizers include nedocromil sodium (e.g., in ALOCRIL®) and lodoxamide(e.g., in ALOMIDE®). Some example anti-fungals include natamycin (e.g.,in NATACYN®) and euconzol. Some example mucolytics includeN-acetylcysteine (e.g., in PARVOLEX). Some example NSAID materialsinclude nepafenac (e.g., in NEVANAC®) and bromfenac (e.g., in BROMDAY®).Some example vasoconstrictors include naphazoline (e.g., in NAPHCON A®)and tetrahydrozoline (e.g., in VISENE®) Some example immunosuppressantsinclude cyclosporine (e.g., in RESTASIS®). All of the aforementionedmaterials include any pharmaceutically acceptable salts thereof.

The fluid treatment composition may be disposed within a fluid containeras provided in the kit. The fluid container may contain any desiredvolume of the treatment composition. Such a volume may be in a rangehaving a lower limit of 0.1, 0.25, 0.5, 0.75 or 1 milliliter and anupper limit of 5, 3 or 2 milliliters. Such a range may be the totaltreatment composition contained within the fluid container or may be thevolume of treatment composition contained within the fluid containerthat is deliverable from the fluid container, which may be referred toas the deliverable volume. The deliverable volume refers to that volumeof fluid in the fluid container that can be effectively delivered from afluid dispenser. The delivery volume may be less than the total volumeof treatment composition contained in the fluid container because ofresidual treatment composition that may be retained in the fluidcontainer or within the fluid dispenser, for example residual treatmentcomposition that may be adhered on internal wall surfaces of (e.g.,internal wall surfaces of the fluid container, for example internal wallsurfaces of a syringe barrel) or that remain in fluid conductionportions of such a fluid dispenser between the fluid container and adistal fluid ejection tip (e.g., remaining fluid in a dispensingneedle).

The fluid container that contains the treatment composition may be partof a fluid dispenser. The fluid dispenser may be manipulable to dispenseat least a portion of the treatment composition from the fluid containerinto the internal passage or through the internal passage directly intoa paranasal sinus following implantation of the implant device. Thefluid container may be provided in the kit by a syringe, which may be orbe part of such a fluid dispenser. The fluid container may include atleast a portion of a syringe barrel. A fluid dispenser may include afluid ejection member in fluid communication with the treatmentcomposition in the fluid container. Such a fluid ejection member may beinsertable in the internal passage of the implant device, and the fluiddispenser may be manipulable when the fluid ejection member is insertedin the internal passage of the implant device when the implant device isimplanted to eject at least a portion of the treatment composition froma distal end of the fluid ejection member into the internal passage ofthe implant device or distal of the distal internal passage directlyinto a paranasal sinus. For example, a distal fluid ejection tip of thefluid ejection member may be disposed in the internal passage and thetreatment composition may be dispensed into the internal passage to thenflow into the paranasal sinus, or the fluid ejection member may beinserted through the internal passage until the distal tip is disposedin the paranasal sinus distal of a distal end of the internal passage,and the treatment composition may be dispensed directly into theparanasal sinus. The fluid ejection member may be connected with asyringe, such as through a leur connection. The fluid ejection membermay have an insertion portion configured to be inserted into theinternal passage and such an insertion portion may have a maximumoutside width (e.g., diameter) of no larger than 1.75 millimeters, nolarger than 1.5 millimeters, no larger than 1.25 millimeters, no largerthan 1 millimeter or no larger than 0.9 millimeter. The fluid ejectionmember may be or include a hollow needle having a blunt tip (e.g., blunttip hypodermic needle). The fluid ejection member may be covered with aremovable protective cap. For example, the kit may include a pre-filledsyringe containing the treatment composition and fitted with ahypodermic needle that is covered with a protective cap that thatprotects the needle prior to use. A kit may include multiple differenttreatment compositions, and may include multiple fluid containers (e.g.,multiple syringes) each containing a different treatment composition.

Forming a fistula for implantation of an implant device to provide afluid passage between the lacrimal apparatus and a paranasal sinusinvolves making a hole through a wall of the bone in which the cavity ofthe paranasal sinus is located. As described herein, such a hole may bemade by a sytlet or other solid piercing instrument and then widened asneeded to form the fistula to the desired size for implantation of theimplant device. For example following the initial piercing to make aninitial hole, the hole may be dilated using dilators to make the holeprogressively larger until the desired size is obtained. However, it hasbeen found that when forming a fistula for implantation in such amanner, the bone tends to crack and shatter in the vicinity of hole.Although this does not present a medical problem, it has been found thatif the bone is kept more in-tact in the vicinity of the hole, then thebone may provide mechanical support to help secure the implant device inplace and prevent the implant device from migrating out of the fistulafollowing implantation. Bone integrity in the vicinity of the fistulamay be improved by cutting the hole for the fistula rather than piercingand dilating the hole. By cutting through the bone, rather than pushingthrough the bone, the bone remains more in-tact in the vicinity of thehole and provides better mechanical support to help retain the implantdevice in place in the fistula following implantation. The implantationkit of the second aspect may include tools useful for cutting a hole fora fistula and implanting an implant device.

A kit may include at least one cutting tool for cutting away tissue toform a fistula through which the implant device may be implanted duringan implant procedure. Such a cutting tool may include a hollow memberhaving a hollow cutting tip at a distal end of the cutting memberconfigured to cut tissue to size the fistula for implantation of theimplant device through the fistula. Such a cutting member may have acutting width that is smaller than a maximum exterior width of a conduitof the implant device configured to be disposed through the fistuladuring implantation. Such a cutting tool may be a drill.

A kit may include a cutting tool that may be guidable by a guide memberdisposable through an internal passage of the cutting tool. The cuttingtool may include a hollow cutting member that has a hollow cutting tipat a distal end of the cutting member configured to cut tissue to sizethe fistula for implantation of the implant device through the fistula.The hollow cutting tip of the cutting tool may be configured to make alarger diameter cut to enlarge a smaller-diameter preliminary cut thatmay have been previously made to accommodate the guide member, or thecutting tool may be configured to make a desired final cut without priorformation of a smaller initial fistula. The cutting member may beconfigured to be slidably engaged with the guide member with the guidemember disposed through a passage in the cutting member with the distalend of the guide member disposed distal of the distal end of the cuttingmember. A distal end of the guide member may be configured to bedisposed in or distal of the fistula such that the cutting member isslidable over the guide member, for example to conduct the cutting tipof the cutting member to cut tissue to size the fistula for implantationof the implant device when a smaller initial fistula has already beenformed or to permit retraction of the cutting member while leaving theguide member in place for use to conduct another tool or tools to thelocation of the fistula, for example an implantation tool for insertingan implant device into the fistula in position for implantationfollowing cutting a fistula of a desired size for implantation.

A cutting member of a cutting tool may be or include a hollow needle ora cutting cannula. The cutting member may have a cutting width, ordiameter in the case of a circular cut, that is smaller than a maximumexterior width of the conduit of the implant device. The maximumexterior width of the conduit of the implant device may occur at one ormore protrusion areas that form part of an anchoring surface feature onthe conduit. The cutting width may be at least 0.1 millimeter smaller,at least 0.2 millimeter smaller, at least 0.25 millimeter smaller, atleast 0.3 millimeter smaller, at least 0.35 millimeter smaller or atleast 0.4 millimeter smaller than the maximum exterior width of theconduit of the implant device. The cutting width may be not more than 1millimeter, 0.75 millimeter, 0.6 millimeter, or 0.5 millimeter smallerthan the maximum exterior width of the conduit. The cutting width may benot larger than 5 millimeters, 4 millimeters, 3.5 millimeters, 3millimeters, 2.5 millimeters, 2.25 millimeters, 2 millimeters, 1.9millimeters or 1.8 millimeters. The cutting width may be at least 1millimeter, 1.5 millimeter, 1.75 millimeter or 1.85 millimeter.

A kit may include an implantation guide tool with a proximal end and adistal end and including a guide member extending longitudinally in adirection from the proximal end toward the distal end of theimplantation guide tool. The guide member and internal passage may beconfigured for mounting the implant device on the guide member with theguide member disposed through the internal passage of the implant devicewith a distal end of the guide member disposed distal of the distal endof the implant device, and the distal end of the guide member may beconfigured to be disposed in or distal of the fistula such that theimplant device mounted on the guide member is slidable on the guidemember toward the distal end of the guide member to conduct the implantdevice into the fistula for implantation. The guide member may beconfigured for insertion through a passage through a tool (e.g., cuttingtool or carrier tool) to guide the tool to the site of a fistula.

In one example of a guide member, the guide member may be a guide wireor a small diameter needle (e.g., 20 gauge spinal needle), a cuttingmember may be a larger gauge needle through which the guide member maybe inserted (e.g., 12 to 14 gauge spinal needle), and an implant devicemay have an internal passage through which the guide member may beinserted (e.g., 1 mm).

The guide member may be any appropriately sized member on which theimplant device or a tool to be guided by the guide member may beslidably conducted along the guide member for implantation. The guidemember may be a rigid, flexible or malleable material. The guide membermay be a solid member, for example a solid guide wire or a stylet. Theguide member may be a hollow member, for example the guide member may beor include a needle or cannula. The guide member may include a cuttingend at the distal end configured to cut tissue to form at least aportion of the fistula. Such a hollow guide member with a cutting endmay be a needle or cutting cannula. Such a hollow guide member with acutting end may be useful to cut an initial hole that may then be madelarger to a desired size for implantation of the implant device.

A kit may include a carrier tool, also referred to as an implantationtool, for carrying the implant device during an implantation procedure.Such a carrier tool may include a carrier member with a distal tip, withthe carrier member being adapted to be disposed through a fistulabetween the lacrimal apparatus in the orbit and a paranasal cavity withthe distal tip located in the paranasal cavity. The carrier tool mayinclude a hand-manipulable handle connected to the carrier member. Animplant device may be mountable on the carrier member for implantationof the implant device, with the mounted implant device disposed betweenthe handle and the distal tip with the carrier member disposed throughthe internal passage and with a proximal end of the implant devicedisposed toward the handle and a distal end of the implant devicedisposed toward the distal tip of the member. When the implant device ismounted for implantation, the carrier member, and the carrier tool, maybe disengageable from the implant device for implantation of the implantdevice during an implantation procedure to provide fluid access to aparanasal sinus. A clearance fit of the carrier member in the internalpassage of the implant device when the implant device is mounted on thecarrier member for implant placement may be small to ensure a close fitand help prevent lateral deformation of the implant device duringimplantation. For example such a clearance fit may be no larger than 0.5millimeter, no larger than 0.4 millimeter, no larger than 0.3millimeter, no larger than 0.2 millimeter or no larger than 0.1millimeter. Having a close fit between of the carrier member in theinternal passage of the implant device helps prevent accordion-likebunching of the implant device during an implant procedure as thecarrier tool with the mounted device may be advanced to advance (push)the carrier member and the mounted implant device into the fistula forimplantation.

Any and all parts of a kit may conveniently be contained within a commonpackage, such as a common box, bag or other common packaging enclosure.Some or all components of a kit may be sterilized and sealed withinhermetically sealed enclosures, such as for example hermetically sealedbags or wrapping.

A third aspect of the disclosure involves a method for performing amedical procedure in relation to a paranasal sinus and/or administeringa treatment composition or performing a medical operation through animplanted implant device directed to the paranasal sinus.

A number of feature refinements and additional features are applicableto the third aspect of the disclosure. These feature refinements andadditional features may be used individually or in any combinationwithin the subject matter of the third aspect or any other aspect of thedisclosure. As such, each of the following features may be, but are notrequired to be, used within any other feature or combination of featuresof the first aspect, the second, the third aspect or any other aspect ofthe disclosure.

A medical procedure of the method of a third aspect may includeimplanting an implant device to provide an artificial fluid path influid communication with the lacrimal apparatus. The method of the thirdaspect may involve cutting away tissue to form a fistula forimplantation of an implant device, which is particularly advantageouswhen the fistula is to pass through bone, such as in the case of implantdevices designed to provide an artificial fluid passage between thelacrimal apparatus and a paranasal sinus. The cutting away tissue may beto form a fistula of a size to receive at least a portion of a conduitof an implant device, the fistula having a proximal end opening into thelacrimal apparatus, and implanting the implant device with at least aportion of the conduit of the implant device in the fistula. Followingthe cutting away tissue, the method may include implanting an implantdevice to fluidly connect the lacrimal apparatus and the paranasalsinus. The implanting may include advancing the implant device into animplantation position using a carrier tool. The implanting may includeadvancing the carrier tool to have the carrier tool push the implantdevice into an implant position. The implanting may include sliding theimplant device along a guide member or along a carrier member of acarrier tool into an implantation position. The implanting may includedisengaging the carrier tool from the implant device positioned in theimplant position.

In one variation, a method of the third aspect may comprise:

cutting away tissue to form a fistula having a proximal end opening intothe lacrimal apparatus and a distal end opening into a paranasal sinus;

implanting an implant device to fluidly connect the lacrimal apparatusand the paranasal sinus, the implanting comprising:

advancing a carrier tool on which the implant device is mounted to pushthe conduit into the fistula from the proximal end of the fistula untilthe implant device is in an implantation position with a distal end ofthe conduit disposed in the paranasal sinus; and

disengaging the carrier tool from the implant device positioned in theimplantation position.

In another variation, a method of the third aspect may comprise:

cutting away tissue to form a fistula of a size to receive at least aportion of a conduit of an implant device, the fistula having a proximalend opening into the lacrimal apparatus;

with a guide member having a distal end disposed in or distal of thefistula, sliding the implant device along the guide member toward thefistula; and

disposing at least a portion of the conduit of the implant device in thefistula.

A method procedure of the method of the third aspect may be or involveadministering a treatment composition to a paranasal sinus through animplant device that fluidly connects the lacrimal apparatus with theparanasal sinus.

A method of the third aspect, or a portion thereof may be performedusing a kit of the second aspect of this disclosure or parts of such akit. When the method includes cutting away tissue, the cutting awaytissue may comprise cutting the tissue with a cutting tool of such akit. During the cutting away or some portion thereof, the cutting membermay or may not be disposed over and conducted to the location for thecut by the guide member. For example, a preliminary cut may be made forform a preliminary hole of a smaller size, the guide member may bedisposed with a distal end in or distal to the preliminary hole, and thecutting member may be slid over the guide member to cut tissue toproduce a larger fistula of the desired size for implantation of theimplant device. As another example, a single final cut may be made tomake a hole of a final desired size for implantation which may be madewithout the aid of a guide member and without making a preliminary hole.In that regard, a shoulder on the ethmoid bone facing the orbit has beenidentified that is a convenient landmark for orienting a cut into theethmoid sinus. The shoulder has been named the shoulder of Willoughby.When the method includes administering a treatment composition to aparanasal sinus the treatment composition may be as described inrelation to the kit of the second aspect.

Cutting away tissue may be accomplished by removing tissue by drillingthrough the tissue with a drill, which drill may be provided in a kit ofthe second aspect. The implant device for the third aspect (or for thesecond aspect) may include:

a proximal end and a distal end at opposite longitudinal ends of theimplant device;

the conduit located between the proximal end and the distal end;

a first internal passage extending between the proximal end and thedistal end of implant device and through the conduit, the first internalpassage having a first end open at the proximal end of the implantdevice and a second end open at the distal end of the implant device;

a longitudinal length between the proximal end and the distal end of theimplant device in a range of from 2 millimeters to 50 millimeters;

a width of the first internal passage transverse to the length in arange of from 0.25 millimeter to 5 millimeters; and

the implant device being configured to be implanted with the proximalend of the implant device disposed in the lacrimal apparatus.

The implant device for the third aspect may be an implant device of thefirst aspect of the disclosure or may include any feature or featuresdescribed with respect to the first aspect of the disclosure, forexample even if the implant device is not according to the first aspect.The implant device may as described with respect to the second aspect ormay have any feature or features described in relation to the secondaspect.

These and other aspects, and features thereof, are further described orwill be apparent from the drawings and the description provided below.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings are included to aid in the understanding of various aspectsof the disclosure and possible feature refinements and additionalfeatures applicable thereto. Features shown in the drawings arepresented for purposes of illustration only, and are not necessarily toscale and are not necessarily detailed in every respect.

FIG. 1 is an illustration showing some example routes for an implant toprovide fluid access from the lacrimal apparatus to a paranasal sinus.

FIG. 2 is perspective view of one embodiment of an implant device.

FIG. 3 is a side view of the same embodiment of an implant device asshown in FIG. 2.

FIG. 4 is an end view of the same embodiment of an implant device asshow in FIG. 2.

FIG. 5 is a partial perspective view of the same embodiment of animplant device as shown in FIG. 2.

FIG. 6 is a partial side view of an embodiment of an implant device.

FIG. 7 is a partial side view of an embodiment of an implant device.

FIG. 8 is an illustration of cross-sections of various configurationsfor anchor protrusions for an implant device.

FIG. 9 is an illustration of various head configurations for an implantdevice.

FIG. 10 shows perspective, top, side and end views of an embodiment ofan implant device.

FIG. 11 shows perspective, top, side and end view of an embodiment of animplant device showing some possible example dimensions.

FIG. 12 shows perspective, top, side and end views of an embodiment ofan implant device.

FIG. 13 shows perspective, top, side and end view of an embodiment of animplant device showing some possible example dimensions.

FIG. 14 is an illustration showing an embodiment for placement of animplant device with a head of the implant device located within theorbit between the lacrimal caruncle and plica semilunaris.

FIG. 15 is an illustration showing use of a surgical tool, in the formof a cutting tool, to form a fistula between the orbit and an ethmoidsinus during a surgical procedure.

FIG. 16 is an illustration showing insertion of a guide wire followingformation of a fistula during a surgical procedure.

FIG. 17 is an illustration showing a guide wire in place as a guide to afistula during a surgical procedure.

FIG. 18 is an illustration showing use of a surgical tool, in the formof a carrier tool, for implantation of an implant device during asurgical procedure.

FIG. 19 is an illustration showing placement of an implant devicefollowing implantation during a surgical procedure.

FIG. 20 illustrates an embodiment of a kit useful for implanting aparanasal sinus access implant device and providing medical treatmentsusing such a paranasal sinus access implant device.

FIG. 21 is a perspective view of an embodiment of an implant device.

DETAILED DESCRIPTION

The terms “lacrimal apparatus” and “lacrimal system” are usedinterchangeably herein to refer to the collection of physiologicalcomponents that accomplish the production and secretion of lacrimalfluid to lubricate the eyeball, containment of lacrimal fluid in areservoir of lacrimal fluid in the orbit and drainage of lacrimal fluidfrom the orbit to the nasal cavity. The lacrimal apparatus includes thelacrimal glands, the tear drainage system and the reservoir of lacrimalfluid located between the lacrimal glands and the tear drainage system.The reservoir of lacrimal fluid includes the eyelid margins and theconjunctival sac (and including the pool of tears in the lowerconjunctival cul-de-sac that is sometimes referred to as the lacrimallake). The tear drainage system includes the puncta, canaliculi andnasolacrimal duct (including the so-called lacrimal sac located at thetop of the nasolacrimal duct) through which excess tears drain toHasner's valve and into the nasal cavity. FIG. 1 shows generally thelacrimal apparatus. Lacrimal fluid is produced and secreted fromlacrimal glands 102 to lubricate the surface of the eyeball 104 disposedwithin the orbit. Lacrimal fluid forms a coating over the eyeball 104and is generally contained within the conjunctival sac (the spacebetween the lower eyelid 106, upper eyelid 108 and eyeball 104 that islined by the conjunctiva). Excess lacrimal fluid is conducted to thevicinity of the medial canthus (medial corner of the eye) and drainsthrough the lacrimal puncta 110 into the lacrimal canaliculi 112 andinto the lacrimal sac 114 of the nasolacrimal duct 116. The lacrimalfluid then drains from the nasolacrimal duct 116 through Hasner's valveand into the nasal cavity.

As used herein, a fistula between the lacrimal apparatus and a paranasalsinus refers to an artificially-created passage that fluidly connectsthe lacrimal apparatus with a paranasal sinus. Such a fistula may besurgically created. The paranasal sinuses include the frontal sinuses,maxillary sinuses, ethmoid sinuses and sphenoid sinuses, which arecavities contained within frontal, maxilla, ethmoid and sphenoid bones,respectively. The paranasal sinuses drain into the nasal cavity. FIG. 1also shows the general proximity of the frontal sinus 122, maxillarysinus 124 and ethmoid sinus 126 relative to features of the lacrimalapparatus and some example fistula routes shown by dashed lines. A firstexample fistula route 130 is from the orbit to the frontal sinus. Asecond example fistula route 132 is from the orbit to the ethmoid sinus126. A third example fistula route 134 is from the orbit to themaxillary sinus 124. A fourth example fistula route 136 is from thelacrimal sac 114 at the top of the nasolacrimal duct 116 to the ethmoidsinus 126. A fifth example fistula route 138 is from the nasolacrimalduct 116 at a location below the lacrimal sac 114 to the ethmoid sinus126. A sixth example fistula route 140 is from the nasolacrimal duct 116at a location below the lacrimal sac 114 to the maxillary sinus 124. Theexample fistula routes shown in FIG. 1 are for purposes of generalillustration only and not to show precise locations where a fistulamight be formed to connect a part of the lacrimal apparatus with thecorresponding paranasal sinus. Although not shown in FIG. 1, examplefistula routes to the sphenoid sinus include from the orbit to thesphenoid sinus and from the nasolacrimal duct 116 to the sphenoid sinus.

FIGS. 2-5 show one embodiment of an implant device, for example that maybe implanted through a fistula at the first, second or third routes 130,132, or 134 shown in FIG. 1. As shown in FIGS. 2-5, an implant device200 has a proximal end 202 and a distal end 204 located on oppositelongitudinal ends of the implant device 200. The implant device 200includes a head 206 at the proximal end 202 and a conduit 208 extendingfrom the head 206 to the distal end 204. An internal passage 210 extendsfrom the proximal end 202 to the distal end 204, passing through thehead 206 and the conduit 208. The internal passage 210 opens at theproximal end 202 and the distal end 204, thereby providing a passagethrough the entire longitudinal length of the implant device 200. Theinternal passage 210 of the embodiment shown in FIG. 2 has a cylindricalshape with a uniform circular cross-section (transverse to the length ofthe implant device 200), and the width of the internal passage is equalto the diameter of the circle of the cross-section and is uniform alongthe length of the implant device 200. The length of the implant device200 is the minimum distance longitudinally along the implant device 200between the proximal end 202 and the distal end 204, and will typicallybe equal to the distance along an axis of the internal passage 210 fromthe proximal end 202 to the distal end 204. The implant device 200includes multiple anchor protrusions 212 on an exterior of the conduit208. In the embodiment shown in FIGS. 2-5, the anchor protrusions 212are in the form of spaced circumferential ridges that each extendsaround the entire circumference of the conduit 208. Adjacent thecircumferential ridges of the anchor protrusions 212 are areas of recess214 on the exterior of the conduit 208.

The head 206 has a flanged tissue engagement surface 216 on a side ofthe head 206 disposed toward the conduit 208, and which flanged tissueengagement surface 216 is advantageously configured to engage tissueadjacent the proximal end of fistula and to prevent the proximal end 202of the implant device 200 from migrating into the fistula followingimplantation. On the side of the head 206 opposite the flanged tissueengagement surface 216 is a face surface 218 of the head 206, which facesurface 218 is disposed away from tissue engaged by the flanged tissueengagement surface 216 when the implant device is implanted. The head206 has a first dimension 220 and a second dimension 222 on both theflanged tissue engagement surface 216 and the face surface 218. Thefirst dimension 220 is the length of the respective surface and thesecond dimension is the width of the respective surface. Such length andwidth dimensions may also be referred to as major and minor dimensions.The first dimension 220 of a surface 216 or 218 corresponds to themaximum separation distance between points on the outer edge of thesurface (maximum cross dimension across the head), and the seconddimension 222 of the surface 216 or 218 corresponds to the maximumseparation distance between points on the outer edge of the surface thatare on a line transverse (perpendicular) to the first dimension.Conveniently, the face surface 218 and the flanged tissue engagementsurface 216 may be made with corresponding outer edges, so that theopposing surfaces 216 and 218 have substantially equal length and widthdimensions, although such is not required. The first dimension 220 andthe second dimension 222 may be referred to generally as the length andwidth, respectively, of the head 206 when the surfaces 216 and 218 havecorresponding shapes, as is the case for the embodiment shown in FIGS.2-5. When the surfaces 216 and 218 do not have corresponding shapes, thelength and width dimensions of the head will be different from one ormore of the length and width dimensions of the surfaces 216 and 218. Thehead 206 has a depth dimension 223 between surfaces 216 and 218.

With continued reference to FIGS. 2-5, the conduit 208 has a firstexterior width 224 that is a maximum exterior width of the conduit 208as defined by the maximum extents of the anchor protrusions 212transverse to the length of the conduit 208. The conduit 208 has asecond exterior width 226 that is a minimum exterior width of theconduit 208 defined between the most recessed portions of the areas ofrecess 214. In the embodiment shown in FIGS. 2-5, the height of theanchor protrusions 212 is equal to one-half the difference between thefirst exterior width 224 and the second exterior width 226 of theconduit 208. In the configuration of the head 206 shown in FIGS. 2-5,the first dimension 220 of the head is larger than both the firstexterior width 224 and the second exterior width 226 of the conduit 208,while the second dimension 222 of the head is approximately equal to thesecond exterior width 224 of the conduit 208.

With continued reference to FIGS. 2-5, the anchor protrusions 212 are inthe form of spaced circumferential ridges having a width that is at amaximum at the bottom of the ridges located adjacent the areas of recess214, and which width tapers to a minimum at the top of the ridges 212located away from the recess areas 214. Other configurations for anchorprotrusions are possible, and all anchor protrusions on an implantdevice need not be of the same size, geometry or height. Likewise, areasof recess may have varying configurations, and not all recesses on animplant device need to be the same size or configuration. The implantdevice 200 has a length 228 including the depth 223 of the head 206 andthe length of the conduit 208. The anchor protrusions 212 are on alongitudinal portion 230 of the conduit 208.

Referring now to FIG. 6, an alternative embodiment is shown of a conduit240 of an implant device having anchor protrusions 242 in the form ofknobs, or buttons, and areas of recess 244 adjacent the anchorprotrusions 242. The conduit 240 has a first exterior width 246 definedby the anchor protrusions 242 and a smaller, second exterior width 248defined by the areas of recess 244. An example of another configurationfor anchor protrusions is shown in FIG. 7. As shown in FIG. 7, a conduit250 of an implant device has anchor protrusions 252 and areas of recess254 on the exterior surface of the conduit 250. The anchor protrusions252 are in the form of a continuous spiral ridge extending along aportion of the longitudinal length of the conduit 250. The conduit 250has a first exterior width 256 defined by the anchor protrusions 254 anda smaller, second exterior width 258 defined by the areas of recess 254.As with the embodiments shown in FIGS. 2-5, the conduit embodimentsshown in FIGS. 6 and 7 include a height of the anchor protrusions thatis equal to one half the difference between the larger and smaller outerdiameters of the respective conduits. As will be appreciated from theembodiments of FIGS. 6 and 7, the first exterior width is determined asthe width of an envelope volume that contains the anchor protrusions.

FIG. 8 shows examples of some shapes for anchor protrusions that includea tapering width in a direction from the base of the anchor protrusiontoward a top of the anchor protrusion. FIG. 8 shows cross-sections ofanchor protrusion configurations (designated A-D), each having a greaterwidth at the base than at the top. The height (H) and base width (W) ofthe anchor protrusions are indicated in FIG. 8.

FIG. 9 shows some different example configurations (designated E-H) fora head for an implant device. For each head configuration, the lengthdimension (L) and width dimension (W) of the head configurations areshown. The heads of configurations E-H are shown on end showing the facesurface (surface facing away from the fistula when implanted) and theopening of the internal passage at the proximal end of the implantdevice. Configurations F-H, with a larger length than width, areadvantageously configured for use with fistulas opening into the orbitbetween the medial canthus and the medial side of the adjacent eyeball,for example between the plica semilunaris and the lacrimal caruncle, andpreferably with the length dimension of the head extending generally ina direction from the bottom of the orbit toward the top of the orbitnext to the eyeball, and for configuration H with the concave side ofthe crescent disposed toward the eyeball and the convex side of thecrescent disposed towards the lacrimal caruncle.

FIG. 10 shows an implant device 700 with a head 702 and a conduit 704.The conduit 704 includes a first longitudinal portion 706 and a secondlongitudinal portion 708 disposed distal of the first longitudinalportion 706. The first longitudinal portion 706 includes a smoothexterior surface and the second longitudinal portion 708 includes ananchoring surface feature including anchor protrusions 710, in the formof spaced circumferential ridges, and recess areas 712 between theanchor protrusions 710. The length of the first longitudinal portion 706located before the beginning of the anchoring surface feature of thesecond longitudinal portion 708 may advantageously be disposed inconjunctival tissue adjacent the head 702 when implanted to “float” forpatient comfort. The anchoring features of the second longitudinalportion 708 may advantageously be located a distance from the head 702so that one or more of the anchor protrusions 710 are located in thevicinity of the paranasal sinus bone wall that is penetrated by theimplant device 700 when implanted, preferably with one or more of theanchor protrusions disposed on each side of the bone. In the embodimentshown in FIG. 10, the exterior width of the conduit 704 is substantiallythe same for the whole length of the first longitudinal portion 706 andin the recess areas 712 of the second longitudinal portion 708. Theconduit 704 has a circular cross-section, so that the exterior width ofthe conduit 704 at any location along the conduit 704 is represented bythe diameter of the circular cross-section of the conduit 704 at thatlocation. As shown in FIG. 10, the implant device 700 has a length 714from a proximal end 716 to a distal end 718 of the implant device 700.The beginning of the second longitudinal portion 708 is located adistance 720 distal from the proximal end 716. The anchor protrusions710 have a width 722 at the base of the anchor protrusions 722 and aheight 724 above the adjacent recess areas 712. The anchor protrusions710 are spaced on a center-to-center spacing 726. The conduit 704 has amaximum exterior width 728 corresponding with the tops of the anchorprotrusions 710, equal to the diameter of the circle of thecross-section through the conduit 704 at the top of the anchorprotrusions 710. The conduit 704 has a minimum exterior width 730 alongthe length of the first longitudinal portion 706 and in the recess areas712 of the second longitudinal portion 708 of the conduit 704, and whichis equal to the diameter of the circular cross-section at thoselocations. The head 702 has a length dimension 732, a width dimension734 and a depth dimension 736. The implant device 700 has an internalpassage 738 extending between the proximal end 716 and the distal end718 and through the length of the conduit 704. The internal passage 738has a width 740, which in this embodiment is equal to a diameter of thecircular cross-section of the internal passage 738. FIG. 11 shows thesame implant device 700 as shown in FIG. 10 with some exemplarydimensions, in millimeters, for one nonlimiting example for aconfiguration for the implant device 702.

FIG. 12 shows an implant device 800 that is similar to the implantdevice 700 shown in FIGS. 10 and 11, except including a firstlongitudinal portion of a conduit having a thicker wall than recessareas of the anchoring surface feature of a second longitudinal portionof the conduit. The thicker wall in the first longitudinal portion ofthe conduit provides added rigidity to that portion of the conduit tofacilitate pushing the implant device 800 into place during animplantation procedure, while the thinner wall in the recess areas ofthe second longitudinal portion of the conduit permit that portion tomore easily deform and fit through a fistula during implantation andthen to expand to engage tissue and anchor the implant device 800. Morespecifically as shown in FIG. 12, the implant device 800 includes a head802 and a conduit 804. The conduit 804 has a first longitudinal portion806 and a second longitudinal portion 808 located distal of the firstlongitudinal portion 806. The first longitudinal portion 806 includes asubstantially smooth exterior surface with a substantially constantexterior width, which is the diameter of the circular cross-section ofthe conduit 804 along the first longitudinal portion 806. The secondlongitudinal portion 808 includes an anchoring surface feature includinganchor protrusions 810, in the form of circumferential ridges, andrecess areas 812 in the spaces between the anchor protrusions 810.Various dimensions of the implant device 802 are illustrated in FIG. 12,similar to the illustration provided for the implant device 700 in FIG.10. The implant device 800 has a length 814 from a proximal end 816 to adistal end 818 of the implant device 800. The beginning of the secondlongitudinal portion 808 is located a distance 820 distal of theproximal end 816. The anchor protrusions have a width 822 at the baseand a height 824 above the adjacent recess areas 812. The anchorprotrusions are spaced on a center-to-center spacing 826. The conduit804, and also the second longitudinal portion 808, has a maximumexterior width 828 occurring at the tops of the anchor protrusions 810,and equal to the diameter of the circular cross-section of the conduit804 through the tops of the anchor protrusions 810. The conduit 804, andthe second longitudinal portion 808, of the conduit 804 have a minimumexterior width 830 located at the recess areas 812. The head 802 has alength dimension 832, a width dimension 834 and a depth dimension 836.The implant device 800 has an internal passage 838 extending between theproximal end 816 and the distal end 818 and through the length of theconduit 804. The internal passage 838 has a width 840, which in theembodiment shown in FIG. 12 is equal to a diameter of the circularcross-section of the internal passage 838.

With continued reference to FIG. 12, the wall thickness of the conduit804, (thickness of the wall between the internal passage 838 and theexterior surface of the conduit 804) is greater along the firstlongitudinal portion 806 than in the recess areas 812 of the secondlongitudinal portion 808. The internal passage 838 has a constant widthalong the length of the conduit 804, such that the greater wallthickness of the conduit 804 along the first longitudinal portion 806results in an exterior width 842 that is larger than the minimumexterior width 830 in the recess areas 812. The maximum exterior width828 at the anchor protrusions 810 is larger than the exterior width 842along the first longitudinal portion 806. FIG. 13 shows some exemplarydimensions, in millimeters, for one nonlimiting example for aconfiguration of the implant device 800.

FIG. 21 shows a variation on the implant device 800 of FIG. 20. Theimplant device 800′ of FIG. 21 has the same features as the implantdevice 800 of FIG. 20, except that the implant device 800′ includes aplurality of side openings 850 (which may also be referred to as holes,apertures or ports) through the wall of a distal portion of the conduit804′. The side openings 850 may be located on a portion of the conduitwall that would be disposed in the paranasal sinus when the implantdevice 800′ is implanted, such that the side openings 850 may provide apassage for fluid communication between the internal passage of theimplant device 800′ and the paranasal sinus even if the distal openingof the internal passage at the distal end of the conduit 804′ were tobecome blocked or restricted for some reason. In the particularimplementation shown in FIG. 21, the implant device 800′ the sideopenings 850 are located in a recess area between a pair ofcircumferential ridges of an anchoring surface feature of the conduit804′. FIG. 21 shows the side openings 850 located in only one recessarea between one pair of circumferential ridges, but one or more similarside openings could also or alternatively be located in a more proximalrecess area between a different pair of the circumferential ridges.

FIG. 14 shows an example of an implant device with a conduit passingthrough a fistula formed from the orbit subconjunctivally between thelacrimal caruncle 142 and the plica semilunaris 144, and showing anexample location for the head 304 of the implant device disposed in theorbit between the lacrimal caruncle 142 and the plica semilunaris 144.The head 304 is shown with an elongated configuration, such as forexample a head configuration shown in any of FIGS. 2-5, FIGS. 10-13, orconfigurations F-H shown in FIG. 11.

Referring now to FIGS. 15-18, some examples of surgical proceduresinvolving forming a fistula and implanting an implant device to provideaccess to a paranasal sinus, and some example surgical tools for usetherewith, will now be described.

In FIG. 15 a surgical tool, in the form of an entry tool 600 is shown inthe process of making a fistula through tissue between the lacrimalcaruncle 142 and the plica semilunaris 144. Numbering of anatomicalparts is the same as in FIG. 1. The fistula is formed through tissuebetween the conjunctival sac in the orbit and the ethmoid sinus 126. Theroute for the fistula would be consistent with general fistula route 132as shown in FIG. 1. The entry tool 600 includes a hollow working member606 with a hollow cutting distal tip 610 with a shape suitable to cutaway tissue to form a fistula from the conjunctival sac to the ethmoidsinus 126. The entry tool 600 may also be referred to as a cutting tooland the working member may also be referred to as a cutting member. Theentry tool 600 includes a hand-manipulable handle 612. The handle 612may be advanced or retracted to advance or retract the hollow workingmember 606. As shown in FIG. 15, the distal cutting tip 610 has beenadvanced from a location in the conjunctival sac between the caruncle142 and the plica semilunaris 144 to form a fistula between theconjunctival sac and the ethmoid sinus 126. As shown, the fistula passesbehind the caruncle 142, canaliculi 112 and nasolacrimal duct 116 toaccess the ethmoid sinus 126.

After the entry tool 600 has been used to initially form a fistula tothe ethmoid sinus 126, then a guide wire or other guide member may beinserted through an internal passage extending through the handle 612and the hollow working member 606. FIG. 16 shows a guide wire 620inserted through the handle 612 and the working member 606. Afterinsertion of the guide wire 620, entry tool 600 may be retracted andremoved from the fistula, leaving the guide wire 620 in place as a guideto and through the fistula, as shown in FIG. 17. The guide wire 620 isnow available for guiding additional tools to and through the fistulainto the ethmoid sinus 126.

With reference now to FIG. 18, the guide wire 620 has been used to guidea surgical tool, in the form of an implant tool 624. The implant toolmay also be referred to as a carrier tool. The implant tool 624 includesa hollow working member 626 and a hand-manipulable handle 628. Theworking member 626 may have a blunt distal tip, as shown in FIG. 18,since the working member 626 may not need to cut additional tissuefollowing formation of the fistula using the entry tool 600, providedthat the fistula has already been formed to a final desired size. Theworking member 626 may also be referred to as a carrier member. Theimplant tool 624 includes an internal passage passing through the handle628 and the hollow working member 626. As shown in FIG. 18, the guidewire 620 has been threaded through the internal passage of the implanttool 624 to guide the hollow working member 626 to and through thefistula and into the ethmoid sinus 126. An implant device 630 is mountedon the hollow working member 626 of the implant tool 624. FIG. 18 showsthe implant tool 624 advanced to a point where the distal end of theimplant device 630 is in the vicinity of the proximal end of the fistulaopening into the conjunctival sac. From this position, the implantdevice 630 may be advanced into the fistula with a head of the implantdevice 630 disposed adjacent the conjunctiva in the conjunctival sac anda distal end of the implant device 630 extending into the ethmoid sinus626. For example, a surgeon may slide the implant device 630 down thehollow working member 626 for placement through the fistula forimplantation or the surgeon may advance the handle 628 to have thehandle push the implant device 630 into the fistula for implantplacement. The outside diameter of the hollow working member 626 may besized to closely fit within the inside diameter of the implant device630 to help prevent the implant device 630 from bunching-up andlaterally deforming as the implant device is pushed into the fistula.The handle 628 and the hollow working member 626 form a carrier for theimplant device 630. The handle 628 may be retracted and the hollowworking member 626 disengaged from the implant device 630 after theimplant device 630 has been appropriately positioned for implantationthrough the fistula. FIG. 19 shows the implant device 630 as implantedand following disengagement of the hollow working member 626 of theimplant tool 624. As implanted, a head 632 at the proximal end of theimplant device 630 is located adjacent the conjunctiva in theconjunctival sac within the orbit between the caruncle 142 and the plicasemilunaris 144 and the distal end 634 of the implant device 630 islocated in the ethmoid sinus 126. Some anchor protrusions 636 of theconduit of the implant device 630 are disposed within the fistula toengage tissue and help anchor the implant device 630. The implant device630 may be used to provide access to the ethmoid sinus 126 to performmedical procedures or treatments, for example to administer a treatmentcomposition to the ethmoid sinus or to aspirate fluid from the ethmoidsinus.

The procedure as described with reference to FIGS. 15-19 permits theworking member 606 of the entry tool 600 to have a larger diameterworking member 626 to form a fistula of appropriate size foraccommodating the implant device 630 which is then implanted in aseparate step using the implant tool 624 with the implant device 630carried on to the working member 626, which may advantageously have asmaller diameter than the working member 606 used to form the fistula.As an alternative, an intermediate step to dilate the fistula or to cutaway additional tissue to a desired hole size for implantation may beperformed between initially forming a fistula with the entry tool 600and implanting the implant device 630 using the implant tool 624.

Referring again to FIG. 15, optionally, one or more procedures may beperformed prior to retracting the hollow working member 606. One or morefluids may be injected through the hollow working member 606. Forexample, contrast media may be injected through the hollowing workingmember 612 and may be imaged to confirm that the fistula has been formedto the proper location prior to proceeding with implantation.

The cutting may be performed, for example, with a cutting tool such as aneedle or cannula that cuts tissue or a drill that drills out thetissue. A method may include cutting an initial hole at the location ofthe desired fistula, and then using a guide member and further tools tocomplete an implantation procedure. For example, the initial cut may beto make a preliminary hole and a larger gauge needle or cutting cannulamay be guided by the guide member to cut the fistula to the finaldesired size for implantation of the implant device. Alternatively, theinitial hole that is cut may be of a final desired size for implantationof the implant device. After the hole has been made to the desired size,the guide member may then be used to guide the implant device or acarrier tool on which the implant device is mounted to the fistula forimplantation of the implant device. As one example, a small gauge needlemay be used to form an initial cut, and a guide wire may then beinserted through the needle and into the fistula to maintain control ofthe fistula. The smaller gauge needle may then be retracted and thesecond cutting tool, in the form of a larger gauge needle, may be slidover the guide wire and conducted to the proper location to cut thefistula to the proper size for implantation of the implant device. A kitfor performing such an operation my include the implant device, thesmaller gauge needle, the guide wire (as the guide member) and thelarger gauge needle as the cutting tool for making the fistula to thefinal desired size. As another example, the initial cutting tool, or aportion thereof may be used as the guide member for the subsequentcutting tool. For example, the initial cut may be made using a smallergauge needle having a handle, such as a spinal needle or similar design.Following the initial cut, the handle, or head, may be cut off andremoved from the smaller gauge needle and a cutting tool in the form ofa larger gauge needle may then be slid over the smaller gauge needle tocut the hole to the final desired size for the fistula. The larger gaugeneedle may then be retracted and the implant device may be slid over thesmaller gauge needle and conducted to the proper location forimplantation. A kit for performing such an operation may include theimplant device, the smaller gauge needle (which serves as the guidemember) and the larger gauge needle as the cutting tool for making thefistula to the final desired size. Alternatively, a kit may include asingle cutting tool (e.g., hollow needle or cutting cannula) sized tocut a hole of the final desired size through which the implant device isto be implanted, and without enlargement by further cutting or dilation.

Referring now to FIG. 20, an example embodiment of a kit is shown thatincludes components for implanting a paranasal access implant device anddelivering a treatment composition to a paranasal sinus through theimplant device. As shown in FIG. 20, a kit 968 includes a paranasalsinus access implant device 970. The implant device 970 may for examplehave any design according to or with features shown or described inrelation to any of FIGS. 2-13, or may have a different design. The kitalso includes a paranasal sinus fluid manipulation tool 972, whichincludes a fluid dispenser in the form of a syringe 974 and a fluidtransmission attachment 976 including a fluid ejection member 977 in theform of a blunt tip hollow needle. The fluid transmission attachment 976includes an engagement structure at a distal end to engage with a headon a proximal end of the implant device 970 to facilitate transmissionof fluid from inside a barrel of the syringe 974 to be ejected from adistal tip of the fluid ejection member 977. The syringe 974 includes apiston 978 disposed in the barrel of the syringe 974 and that is handmanipulable by advancement or retraction of a plunger 980 to move thepiston 978 in the syringe barrel to create pressure to expel fluid fromthe syringe barrel through the fluid transmission attachment 976 or tocreate a vacuum to suction fluid through the fluid transmissionattachment 976 into the syringe barrel. The fluid manipulation tool 972may be provided with the syringe 974 and the fluid transmissionattachment 976 assembled as shown in FIG. 20, or may be provided withthe syringe 974 and the fluid transmission attachment 976 as separate,disassembled pieces that are assemblable into the assembly as shown inFIG. 20. In some preferred implementations, the syringe 974 may beprefilled with a treatment composition disposed inside the barrel of thesyringe 974. Such a prefilled syringe 974 may be provided in the kit 968assembled with the fluid transmission attachment 976 as shown in FIG.20, and preferably with a protective cap covering the fluid transmissionattachment 976, and which cap is removable by a medical practitioner foruse of the fluid manipulation tool 972 to administer a treatmentcomposition to a patient in which the implant device 970 has beenimplanted to provide access to a paranasal sinus. A treatmentcomposition disposed in the barrel of the syringe 974 may be anirrigation liquid or a drug composition, for example as previouslydescribed.

The kit 968 as shown in FIG. 20 also includes tools for forming afistula between the lacrimal apparatus in the orbit and a paranasalsinus, for example a frontal, maxillary or ethmoid sinus. As shown inFIG. 20, the kit 968 includes a cutting tool 982 having a hollow cuttingmember 984 (e.g., hollow needle) for cutting away tissue to form afistula of a size suitable for implantation of the implant device 972without enlargement by further cutting or dilation. Alternatively a kitcould include a cutting tool with a smaller gauge cutting member orpiercing member to form an initial hole and one or more additional tools(e.g., cutting tool with larger gauge cutting member and/or dilator) maybe included in a kit to enlarge the initial hole to a final desired sizefor implantation. The cutting tool 982 may for example have a designaccording to or including features as shown or described in relation toeither of FIGS. 15 and 16, or may be of a different design.

The kit 968 as shown in FIG. 20 also includes a carrier tool 986 havingan carrier member 988, which has an outside diameter sized for insertionof the carrier member 988 through the internal passage of the implantdevice 970 to mount the implant device 970 on the carrier member 988 tocarry the implant device 970 for implantation after a fistula has beenformed to a desired size. The carrier tool 986 may for example have adesign according to or including any features as shown in or describedin relation to FIG. 18 or may be of a different design. The carrier tool986 and the implant device 970 may be provided in the kit 968 asseparate, assemblable pieces such as is shown in FIG. 20. Alternatively,the carrier tool 986 and the implant device 970 may be provided in thekit with the implant device 970 pre-mounted on the carrier member 988 ina configuration ready for use in an implantation procedure.

The fluid ejection member 977 is configured to be inserted into aninternal passage that extends through the implant device 970. Afterimplantation of the implant device 970 to provide access to a paranasalsinus, the fluid ejection member 977 may be inserted into the internalpassage from the proximal end of the implant device 970 that is disposedin the orbit following implantation. After insertion of the fluidejection member 977 into the internal passage of the implant device 970,the plunger 980 may be pushed to advance the piston 978 to forcetreatment composition in the barrel of the syringe 974 to flow to and beejected from the distal tip of the fluid ejection member 977. The fluidejection member 977 may be inserted into the internal passage of theimplant device 970 so that the distal tip of the fluid ejection member977 is disposed in the internal passage when the treatment compositionis ejected and the treatment composition is ejected into the internalpassage from which the treatment composition may flow to the paranasalsinus. Alternatively, the injection member 977 may be inserted into theinternal passage of the implant device 970 until the distal end of theinjection member exits a distal end of the internal passage into theparanasal sinus, in which case the treatment composition may be ejectedfrom the fluid ejection member 977 directly into the paranasal sinus.

The cutting tool 982 and the carrier tool 986 may have internal passagestherethrough for insertion of a guide member (e.g., a guide wire). A kitmay include such a guide wire or other guide member.

A variety of medical treatments and procedures may be performed througha paranasal sinus access implant device implanted to provide access to aparanasal sinus. Fluid treatment compositions may be administered to aparanasal sinus through the implant device. Fluid may be aspirated froma paranasal sinus through the implant device. One or more medicaldevices may be inserted into the paranasal sinus through the implantdevice.

The foregoing discussion of the invention and different aspects thereofhas been presented for purposes of illustration and description. Theforegoing is not intended to limit the invention to only the form orforms specifically disclosed herein. Consequently, variations andmodifications commensurate with the above teachings, and the skill orknowledge of the relevant art, are within the scope of the presentinvention. The embodiments described hereinabove are further intended toexplain best modes known for practicing the invention and to enableothers skilled in the art to utilize the invention in such, or other,embodiments and with various modifications required by the particularapplications or uses of the present invention. It is intended that theappended claims be construed to include alternative embodiments to theextent permitted by the prior art. Although the description of theinvention has included description of one or more possibleimplementations and certain variations and modifications, othervariations and modifications are within the scope of the invention,e.g., as may be within the skill and knowledge of those in the art afterunderstanding the present disclosure. It is intended to obtain rightswhich include alternative embodiments to the extent permitted, includingalternate, interchangeable and/or equivalent structures, functions,ranges or steps to those claimed, whether or not such alternate,interchangeable and/or equivalent structures, functions, ranges or stepsare disclosed herein, and without intending to publicly dedicate anypatentable subject matter. Furthermore, any feature described or claimedwith respect to any disclosed implementation may be combined in anycombination with one or more of any other features of any otherimplementation or implementations, to the extent that the features arenot necessarily technically incompatible, and all such combinations arewithin the scope of the present invention.

The terms “comprising”, “containing”, “including” and “having”, andgrammatical variations of those terms, are intended to be inclusive andnonlimiting in that the use of such terms indicates the presence of somecondition or feature, but not to the exclusion of the presence also ofany other condition or feature. The use of the terms “comprising”,“containing”, “including” and “having”, and grammatical variations ofthose terms in referring to the presence of one or more components,subcomponents or materials, also include and is intended to disclose themore specific embodiments in which the term “comprising”, “containing”,“including” or “having” (or the variation of such term) as the case maybe, is replaced by any of the narrower terms “consisting essentially of”or “consisting of” or “consisting of only” (or the appropriategrammatical variation of such narrower terms). For example, a statementthat some thing “comprises” a stated element or elements is alsointended to include and disclose the more specific narrower embodimentsof the thing “consisting essentially of” the stated element or elements,and the thing “consisting of” the stated element or elements. Examplesof various features have been provided for purposes of illustration, andthe terms “example”, “for example” and the like indicate illustrativeexamples that are not limiting and are not to be construed orinterpreted as limiting a feature or features to any particular example.The term “at least” followed by a number (e.g., “at least one”) meansthat number or more than that number. The term “at least a portion”means all or a portion that is less than all. The term “at least a part”means all or a part that is less than all.

The features in the drawings are shown for illustration purposes and togenerally show relative positioning and interaction, and the featuresshown are not necessarily to scale.

1. A paranasal sinus access implant device useful for implantation in ahuman to fluidly connect a lacrimal apparatus to a paranasal sinusthrough a fistula formed between the lacrimal apparatus and theparanasal sinus, the implant device comprising: a proximal end at afirst longitudinal end of the device; a distal end at a secondlongitudinal end of the device that is longitudinally opposite the firstlongitudinal end; a conduit between the proximal end and the distal end;an internal passage through the conduit; a length of the implant devicelongitudinally along the device between the proximal end and the distalend in a range of from 2 millimeters to 50 millimeters; a width of theinternal passage transverse to the length in a range of from 0.25millimeter to 5 millimeters; the conduit including a first longitudinalportion having a length of from 5 millimeters to 12 millimeters and asecond longitudinal portion located toward the distal end relative tothe first longitudinal portion, the second longitudinal portion having alength of from 5 millimeters to 20 millimeters; the first longitudinalportion of the conduit having a first maximum exterior width; the secondlongitudinal portion of the conduit including an anchoring surfacefeature with at least 3 spaced circumferential ridges spaced along thesecond longitudinal portion of the conduit, wherein each saidcircumferential ridge extends around the entire circumference of theconduit, and with recess areas between the circumferential ridges; thesecond longitudinal portion of the conduit having a second maximumexterior width at a said circumferential ridge; the first longitudinalportion of the conduit being in the absence of said circumferentialridges and the second maximum exterior width being larger than the firstmaximum exterior width; and a plurality of side ports through a wall ofthe second longitudinal portion of the conduit to provide passages forfluid communication between the internal passage and the paranasalsinus, wherein the plurality of side ports are located in a said recessarea between a pair of adjacent circumferential ridges; the implantdevice configured to be implanted to fluidly connect the lacrimalapparatus to the paranasal sinus so that when implanted: the proximalend is disposed in the lacrimal apparatus; the distal end is disposed inthe paranasal sinus; and the conduit is disposed through the fistulabetween the lacrimal apparatus and the paranasal sinus with at least aportion of each of the first longitudinal portion and the secondlongitudinal portion of the conduit disposed within the fistula and withat least a portion of the second longitudinal portion of the conduitincluding the side ports disposed in the paranasal sinus.
 2. (canceled)3. An implant device according to claim 1, wherein the firstlongitudinal portion of the conduit has a smooth exterior surface. 4-10.(canceled)
 11. An implant device according to claim 1, wherein: thefirst maximum exterior width is within a range of from 1.75 millimetersto 2.25 millimeters; the second maximum exterior width is in a range offrom 2 millimeters to 3 millimeters; and the second maximum exteriorwidth is at least 0.2 millimeter larger than the first maximum exteriorwidth.
 12. An implant device according to claim 11, wherein; thecircumferential ridges have a height relative to the recess areas in arange of from 0.2 millimeter to 0.5 millimeter; and the circumferentialridges have a center-to-center spacing in a range of from 1 millimeterto 2 millimeters. 13-16. (canceled)
 17. An implant device according toclaim 12, wherein: the circumferential ridges are configured to flexiblydeform when contacting the tissue exposed in the fistula when theconduit is inserted through the fistula for implantation.
 18. An implantdevice according to claim 12, comprising a head adjacent the conduit atthe proximal end, wherein: the head comprises a flanged tissueengagement surface on a side of the head disposed toward the conduit andconfigured to engage tissue outside of and adjacent to the fistula whenthe implant device is implanted; the head has a first dimension that isa maximum separation distance between points on the outer edge of theflanged tissue engagement surface, the first dimension being larger thanan exterior width of the conduit defined by an extent of the protrusionareas transverse to the length of the device; and the head has a seconddimension transverse to the first dimension that is a maximum separationdistance between points on the outer edge that are on a line transverseto the first dimension, and a ratio of the first dimension to the seconddimension in a range of from 1 to
 4. 19. An implant device according toclaim 18, wherein the length of the implant device is in a range of from12 millimeters to 30 millimeters.
 20. An implant device according toclaim 18, wherein the conduit is constructed of polymeric materialhaving a durometer (Shore A) in a range of from 50 to
 100. 21.(canceled)
 22. A kit for use to treat a paranasal sinus, the kitcomprising: a paranasal sinus access implant device according to claim18; and at least one cutting tool for cutting away tissue to form afistula through which the implant device may be implanted during animplantation procedure.
 23. A kit according to claim 22, comprising adrug treatment composition deliverable to a paranasal sinus through theimplant device following implantation of the implant device to provideaccess to the paranasal sinus. 24-29. (canceled)
 30. A kit according toclaim 23, wherein the drug treatment composition comprises any one ormore of the following in any combination: an antibiotic, a steroid, ananti-viral, an antihistamine, an anti-fungal, a mast cell stabilizer, amucolytic, a non-steroidal anti-inflammatory drug (NSAID), avasoconstrictor, and an immunosuppressant. 31-32. (canceled)
 33. A kitaccording to claim 22, wherein the at least one cutting tool comprises ahollow member having a hollow cutting tip at a distal end of the cuttingmember configured to cut tissue to size the fistula for implantation ofthe implant device through the fistula.
 34. A kit according to claim 33,wherein: the cutting member has a cutting width that is smaller than amaximum exterior width of a conduit of the implant device configured tobe disposed through the fistula during implantation; and the cuttingwidth is not more than 0.75 millimeter smaller than the maximum exteriorwidth of the conduit.
 35. (canceled)
 36. A kit according to claim 34,wherein the cutting width is in a range of from 1.5 millimeters to 2.5millimeters and the maximum exterior width of the conduit of the implantdevice is in a range of from 2.0 to 2.75 millimeters. 37-38. (canceled)39. An implantation kit according to claim 36, comprising: a carriertool for carrying the implant device during an implantation procedure,the carrier tool comprising: a carrier member with a distal tip, thecarrier member being adapted to be disposed through a fistula betweenthe lacrimal apparatus in the orbit and a paranasal cavity with thedistal tip located in the paranasal cavity; and a hand-manipulablehandle connected to the carrier member; wherein: the implant device ismountable on the carrier member for implantation with the mountedimplant device disposed between the handle and the distal tip with thecarrier member disposed through the internal passage and with a proximalend of the implant device disposed toward the handle and a distal end ofthe implant device disposed toward the distal tip of the member; andwhen the implant device is mounted for implantation, the carrier isdisengageable from the implant device for implant placement of theimplant device during an implantation procedure to provide fluid accessto a paranasal sinus; and a guide member having a distal end configuredto be disposed in or distal of a fistula formed between the lacrimalapparatus and the paranasal sinus; wherein: the cutting tool comprisesan internal passage through which the guide member may be inserted suchthat cutting tool may slidably engaged with the guide member while thedistal end of the guide member is disposed in the fistula; and thecarrier tool comprises an internal passage through which the guidemember may be inserted while the distal end of the guide member isdisposed in the fistula to guide the carrier tool to the site of thefistula for implantation of the implant device.
 40. An implant deviceaccording to claim 18, wherein the pair of adjacent circumferentialridges is a most distally located pair of adjacent said circumferentialridges on the conduit.
 41. An implant device according to claim 40,wherein the plurality of side ports between the most distally locatedpair of adjacent circumferential ridges comprises at least 3 said sideports each disposed at a different radial location around acircumference of the conduit between the most distally located pair ofadjacent circumferential ridges.
 42. An implant device according toclaim 41, wherein the plurality of side ports between the most distallylocated pair of adjacent circumferential ridges comprises at least 2said side ports each disposed at a different longitudinal location alonga length of the conduit between the most distally located pair ofadjacent circumferential ridges.
 43. An implant device according toclaim 41, comprising at least 5 of the circumferential ridges.
 44. Animplant device according to claim 41, comprising only 5 or only 6 of thecircumferential ridges.